COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04541680

Bruno Crestani, MD,PHD

bruno.crestani@aphp.fr

2020-09-09

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Long covid

inclusion criteria: - history of hospitalization for covid-19 infection documented with positive pcr or positive serology in the previous 2 to 12 months - lung opacities on hrct involving more than 10% of the lung volume, with fibrotic features - dlco≤ 70% of the predicted value

pre-existing lung disorder with abnormal hrct (including copd, lung cancer, or pulmonary fibrosis) laboratory parameter thresholds: renal insufficiency with following criteria: creatinine clearance <30 ml/min estimated by the cockcroft-gault equation. any of the following liver test criteria above the specified limit: total bilirubin > 1.5 above the upper limit of the normal range (uln), except in patients with predominantly unconjugated hyperbilirubinemia (e.g., gilbert's syndrome). aspartate or alanine aminotransferase (ast or alt) >3 × uln (refer to the protocol, table 3 p 34 for the management of liver enzyme elevation). recent surgery with wound healing in progress(<7days ) patients with underlying chronic liver disease (child pugh a, b or c hepatic impairment). significant pulmonary arterial hypertension (pah) defined by any of the following: previous clinical or echocardiographic evidence of significant right heart failure history of right heart catheterisation showing a cardiac index ≤2 l/min/m² pah requiring parenteral therapy with epoprostenol/treprostinil. history of cardiovascular diseases, any of the following: severe hypertension, uncontrolled under treatment (≥160/100 mmhg), within 6 months of visit 1 myocardial infarction within 6 months of visit 1 unstable cardiac angina within 6 months of visit 1. bleeding risk, any of the following: known genetic predisposition to bleeding. patients who require i. fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin k antagonists, direct thrombin inhibitors, heparin, hirudin) ii. high dose antiplatelet therapy. alcohol or drug abuse which in the opinion of the treating physician would interfere with treatment. ongoing or past antifibrotic treatment with pirfenidone or nintedanib hypersensitivity to nintedanib, peanut or soya or to any of the excipients of the specialty ofev® patients not able to understand and follow study procedures including completion of self-administered questionnaires without help. no written informed consent from the patient absence of affiliation to the french social security participation in another interventional research

2

Assistance Publique - Hôpitaux de Paris

18

89

France

Patients recovered from covid

N/A

250

The primary objective is to assess whether nintedanib slows the progression of lung fibrosis in COVID-19 survivors as assessed by the decline in the forced vital capacity (FVC) over 12 months compared to placebo.

None

Phase 3

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